Immediate versus conventional loading of palatal implants in humans: a first report of a multicenter RCT

Abstract

This study aims to analyze the clinical performance of two loading concepts on second-generation palatal implants (Orthosystem, Straumann, Basel, Switzerland) in a prospective multicenter randomized controlled clinical trial. At the time of this interim analysis, 41 patients have been randomized on a 1:1 basis to one of two treatment groups. Group 1 underwent conventional loading of palatal implants after a healing period of 12weeks (gold standard) while group 2 underwent immediate implant loading within 1week after implant insertion. We report initial results at 6months after functional loading. The primary outcome parameter was implant success (no implant mobility, no implant loss). The implants in both groups were initially stable at the time of insertion, and all were eligible for randomization. Twenty-two patients (group 1) were subjected to conventional implant loading after 12weeks while 19 patients (group 2) received immediate functional loading within the first week after insertion. Direct (e.g. distal jet appliances) as well as indirect forms of anchorage (conventional or modified transpalatal arch) were used. The magnitude of orthodontic forces ranged between 1 and 4N for the immediate loading group and between 1 and 5N for the conventional loading group. One implant in group 1 was lost during the healing phase. One dropout was registered in group 2. Thirty-nine implants were functionally loaded for over 6months now. These preliminary data provide first evidence of the fact that immediate loading of palatal implants yields equivalent success rates as conventional loading to 4N after 6months.